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Fertility IssuesNCT06127875

Effects of Trying to Conceive Using an Home- or Hospital-based Ovulation Monitoring on Stress

An observational study of Fertility Issues and Stress, Psychological, run by The First Hospital of Jilin University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this observational study is to compare the difference of stress level and anxiety and depression between couples under home ovulation monitoring and hospital ultrasound monitoring.And whether it has a negative effect on the couple's sexual behavior.The participants were all healthy couples with fertility… Read more about this study

Who is it for?
Ages 20 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Fertility Issues, Stress, Psychological
How many people
311 participants
Where
1 siteChina
Study dates
1 Nov 2023to 9 Nov 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: The recruiters are all couples seeking to conceive from the Reproductive Center of a university affiliated hospita. All couples are healthy. They have normal sexual intercourse without contraception, and not pregnant for more than six months.

Who may be able to join

  • Normal sexual activity, no contraception for more than six months, and no ovulation monitoring in any way before Preparing for ovulation monitoring

Who cannot join

  • Couples with contraindications to pregnancy The man was diagnosed with severe oligozoospermia and azoospermia

Trial locations and contacts

1 site in 1 country.

China1 site

  • the first hospital of Jilin University

    Changchun, Jilin, 130000

Other trials in China

About this study

The goal of this observational study is to compare the difference of stress level and anxiety and depression between couples under home ovulation monitoring and hospital ultrasound monitoring.And whether it has a negative effect on the couple's sexual behavior.The participants were all healthy couples with fertility requirements from the reproductive Center of the First Hospital of Jilin University.The main questions it aims to answer are:

  • [question1] : Does ultrasound monitoring of ovulation increase stress levels and anxiety and depression in couples trying to conceive?
  • [question2] : Does ovulation monitoring affect couples' sexual function and satisfaction? Participants will be asked to fill out questionnaires three times over four menstrual cycles.
Read the detailed description

The goal of this observational study is to compare the difference of stress level and anxiety and depression between couples under home ovulation monitoring and hospital ultrasound monitoring.And whether it has a negative effect on the couple's sexual behavior.The participants were all healthy couples with fertility requirements from the reproductive Center of the First Hospital of Jilin University.

Each couple needs to complete three questionnaires, one after informed consent, the second after two menstrual cycles, and the third after four menstrual cycles. If the woman becomes pregnant within 4 cycles, the investigation will be stopped.

The study was divided into two groups，home ovulation monitoring group and hospital ovulation monitoring group.The questionnaires used were the Perceived Stress Scale (PSS) , the Hospital Anxiety and Depression Scale (HADS) ,Sexual functioning was assessed with the Female Sexual Function Index (FSFI) ,the International Index of Erectile Function (IIEF) and premature ejaculation diagnostic tool（PEDT）.

Keywords
Psychological stress, Ovulation Monitoring, anxiety, depression, Sexual intercourse
Medical subject headings
Infertility, Stress, Psychological, Anxiety Disorders, Depression, Coitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06127875
Study groupRoleWhat they receive
Home Ovulation Monitoring Grouptimed intercourse by predicting the ovulation period or using ovulation test strips
Hospital Ovulation Monitoring Grouptimed intercourse by ultrasound ovulation monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Will hospital ovulation monitoring increase stress levels in couples?

    The questionnaires used were the Perceived Stress Scale (PSS). The instrument uses a 5-point Likert scale rating from "0 = never" to "4=very often"for 14 items. Scores can range from 0 to 56, with higher score indicates greater psychological stress. Compare whether there are differences between hospital ovulation monitoring and home ovulation monitoring.

    Measured: A year

  2. Will hospital ovulation monitoring increase anxiety and depression in couples?

    The questionnaires used were the Hospital Anxiety and Depression Scale (HADS). Each domain has seven items with score ranges of 0 to 3, and total scores of 0 to 21. Higher scores indicate higher levels of anxiety and depression. Compare whether there are differences between hospital ovulation monitoring and home ovulation monitoring.

    Measured: A year

Secondary outcomes (1)

  1. The impact of two sets of ovulation monitoring methods on sexual function

    Sexual functioning was assessed with the Female Sexual Function Index (FSFI) for female and the International Index of Erectile Function (IIEF) and premature ejaculation diagnostic tool（PEDT） for male. Compare whether there are differences between hospital ovulation monitoring and home ovulation monitoring

    Measured: A year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2023
  2. Study start1 Nov 2023
  3. Primary completion19 Sep 2024
  4. Study completion9 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
311 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06127875
Sponsor's protocol ID
2023-HS-115
Status last verified
Oct 2024
First submitted
8 Nov 2023
Last updated
19 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zegers-Hochschild F, Adamson GD, Dyer S, Racowsky C, de Mouzon J, Sokol R, Rienzi L, Sunde A, Schmidt L, Cooke ID, Simpson JL, van der Poel S. The International Glossary on Infertility and Fertility Care, 2017. Fertil Steril. 2017 Sep;108(3):393-406. doi: 10.1016/j.fertnstert.2017.06.005. Epub 2017 Jul 29.

    PubMed 28760517

  • Behre HM, Kuhlage J, Gassner C, Sonntag B, Schem C, Schneider HP, Nieschlag E. Prediction of ovulation by urinary hormone measurements with the home use ClearPlan Fertility Monitor: comparison with transvaginal ultrasound scans and serum hormone measurements. Hum Reprod. 2000 Dec;15(12):2478-82. doi: 10.1093/humrep/15.12.2478.

    PubMed 11098014

  • Tiplady S, Jones G, Campbell M, Johnson S, Ledger W. Home ovulation tests and stress in women trying to conceive: a randomized controlled trial. Hum Reprod. 2013 Jan;28(1):138-51. doi: 10.1093/humrep/des372. Epub 2012 Oct 18.

    PubMed 23081872

  • Weddell S, Jones GL, Duffy S, Hogg C, Johnson S, Ledger W. Home ovulation test use and stress during subfertility evaluation: Subarm of a randomized controlled trial. Womens Health (Lond). 2019 Jan-Dec;15:1745506519838363. doi: 10.1177/1745506519838363.

    PubMed 30924413

  • Martins MV, Fernandes J, Pedro J, Barros A, Xavier P, Schmidt L, Costa ME. Effects of trying to conceive using an every-other-day strategy versus fertile window monitoring on stress: a 12-month randomized controlled trial. Hum Reprod. 2022 Nov 24;37(12):2845-2855. doi: 10.1093/humrep/deac228.

    PubMed 36272105

  • Ahn SH, Lee I, Cho S, Kim HI, Baek HW, Lee JH, Park YJ, Kim H, Yun BH, Seo SK, Park JH, Choi YS, Lee BS. Predictive Factors of Conception and the Cumulative Pregnancy Rate in Subfertile Couples Undergoing Timed Intercourse With Ultrasound. Front Endocrinol (Lausanne). 2021 Apr 15;12:650883. doi: 10.3389/fendo.2021.650883. eCollection 2021.

    PubMed 33935968

  • Gibbons T, Reavey J, Georgiou EX, Becker CM. Timed intercourse for couples trying to conceive. Cochrane Database Syst Rev. 2023 Sep 15;9(9):CD011345. doi: 10.1002/14651858.CD011345.pub3.

    PubMed 37709293

  • Song SH, Kim DS, Yoon TK, Hong JY, Shim SH. Sexual function and stress level of male partners of infertile couples during the fertile period. BJU Int. 2016 Jan;117(1):173-6. doi: 10.1111/bju.13201. Epub 2015 Jul 14.

    PubMed 26074135

  • Xi Q, Kong Q, Lv X, Dai R, Yu Y. Impact of ejaculation frequency on semen parameters and DNA fragmentation: a cross-sectional study. Reprod Biol Endocrinol. 2025 Jul 16;23(1):100. doi: 10.1186/s12958-025-01439-3.

    PubMed 40671092

Questions about this trial

What is this clinical trial studying?

An observational study of Fertility Issues and Stress, Psychological, run by The First Hospital of Jilin University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Will hospital ovulation monitoring increase stress levels in couples? (time frame: A year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06127875, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.

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